Extended Post-operative Oral TXA in Primary THA
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOregon Health and Science University
About this trial
The goal of this clinical trial is to learn if extended post-operative oral tranexamic acid (TXA) - a medication that reduces bleeding by slowing the breakdown of blood clots - can improve functional recovery following surgery in adults undergoing primary total knee or hip arthroplasty for osteoarthritis. The main question it aims to answer is: Does extended post-operative oral TXA improve functional outcomes at 6 weeks post-operatively compared to standard perioperative TXA alone? Researchers will compare patients receiving extended oral TXA to patients receiving matching placebo capsules on the same schedule to see if the extended TXA regimen reduces blood loss, improves early functional outcomes, and reduces pain without increasing complication rates. Participants will receive standard perioperative oral TXA (1.95 g) prior to surgical incision, along with standard VTE prophylaxis. They will be randomly assigned to receive either oral TXA or matching placebo capsules once daily on post-operative days 1, 2, and 3. Participants will attend follow-up visits at 2, 6, and 12 weeks post-operatively to complete functional outcome questionnaires, pain assessments, and - for knee replacement patients - range of motion measurements.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Undergoing primary total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis
Ability to provide written informed consent
Willingness to comply with study protocol
Disqualifiers
History of venous thromboembolism (DVT or PE)
Active malignancy
Allergy or contraindication to tranexamic acid (TXA)
Post-operative anticoagulation therapy other than aspirin
Trial design
Design model
Parallel
Treatments tested in this trial
Extended oral tranexamic acid regimen
DrugParticipants in the intervention group will receive 1.95mg of oral tranexamic acid on post-operative day 1, 2, and 3.
Placebo
DrugPatients will receive an oral placebo medication on post-operative day 1, 2, and 3.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Extended Oral TXAExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
6-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 6 weeks post-operatively. Scale for booth outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Time frame
At 6 weeks from timing of surgical interventionSecondary outcomes
1
2-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 2 weeks post-operatively. Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Time frame
At 2 weeks from timing of surgical intervention2
12-week Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) score
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) for patients undergoing Total Knee Arthroplasty or Hip injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) for patients undergoing Total Hip Arthroplasty at 12 weeks post-operatively. Scale for both outcome scores is 0 to 100, with a higher score representing improved patient-reported knee or hip health.
Time frame
At 12 weeks from timing of surgical intervention3
2-week Visual Analog Scale (VAS) pain score
Visual analog scale (VAS) pain score at 2 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.
Time frame
At 2 weeks from timing of surgical intervention4
6-week Visual Analog Scale (VAS) pain score
Visual analog scale (VAS) pain score at 6 weeks post-operatively. Scale is 0-10 with higher scores representing more pain.
Time frame
At 6 weeks from timing of surgical interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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